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RSS FeedPosted by Michael Wonder on 17 May 2024
HLB shares plummet following FDA rejection of liver cancer drug approval
17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 14 May 2024
Baxter secures FDA approval of Clinolipid (lipid injectable emulsion) neonatal and paediatric indication
13 May 2024 - Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...
Posted by Michael Wonder on 07 May 2024
Azurity Pharmaceuticals announces FDA approval of Myhibbin (mycophenolate mofetil oral suspension)
6 May 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Myhibbin, the only ready to use mycophenolate ...
Posted by Michael Wonder on 02 May 2024
Labcorp receives FDA approval for first companion diagnostic for use with Pfizer's newly approved gene therapy to treat patients with haemophilia B
29 April 2024 - Labcorp today announced the U.S. FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Aquestive Therapeutics receives US FDA approval and market access for Libervant (diazepam) buccal film in paediatric patients ages 2 to 5
29 April 2024 - Announces immediate availability of Libervant 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg for ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves first drug for WHIM syndrome, a rare disorder that can lead to recurrent, life threatening infections
29 April 2024 - The US FDA has approved Xolremdi (mavorixafor) capsules in patients 12 years of age and older with ...
Posted by Michael Wonder on 29 Apr 2024
FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
29 April 2024 - Today, the FDA granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen) for recurrent or metastatic cervical ...
Posted by Michael Wonder on 26 Apr 2024
US FDA approves Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with hemophilia B
26 April 2024 - Pfizer announced today that the US FDA has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults ...
Posted by Michael Wonder on 25 Apr 2024
FDA approves new treatment for uncomplicated urinary tract infections
24 April 2024 - Today, the US FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 23 Apr 2024
Abeona Therapeutics provides regulatory update on Pz-cel
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...